Medical valve with fluid escape space

ABSTRACT

A medical valve has a body and a flexible element. The body includes a wall structure defining an internal cavity having an inside and an outside. The body also has a proximal end and a distal end. The proximal end has an opening sufficiently large to receive a tip of a delivery end of a medical implement which transfers fluid through the delivery end. The body has a fluid escape space in its wall structure. The flexible element is adapted to be moved into a compressed state upon insertion of the tip of the medical implement into the opening. The flexible element is sufficiently resilient to return to a decompressed state upon removal of the tip of the medical implement from the opening. The fluid escape space is in fluid communication with the outside of the cavity when the seal is in its compressed state.

RELATED APPLICATIONS

[0001] This application is a continuation of U.S. application Ser. No.10/004,561, filed on Dec. 4, 2001, which was a continuation of U.S.application Ser. No. 09/495,559, filed on Feb. 1, 2000, now U.S. Pat.No. 6,325,782, which was a continuation of U.S. application Ser. No.09/055,646, filed on Apr. 6, 1998, now U.S. Pat. No. 6,019,748, whichwas a continuation of U.S. application Ser. No. 08/572,934, filed onDec. 15, 1995, now U.S. Pat. No. 5,738,663.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates to a closed, patient access system whichautomatically reseals after administering medication using a standardmedical implement that directly connects with the system without theneed of any intermediary needles, caps or adaptors. A two-way valveeliminating dead space is used which includes a seal which, upon beingcompressed by the medical implement, is pierced to open the valve andreseals upon being decompressed, maintaining a fluid tight seal even athigh pressures and after repeated uses.

[0004] 2. Backgound Discussion

[0005] The manipulation of fluids for parenteral administration inhospital and medical settings routinely involves the use of connectorsand adaptors for facilitating the movement of fluids between two points.Most fluid connectors and adaptors employ needles to pierce a septumcovering sterile tubing or to pierce the septum of a medicamentcontainer of fluid. Fluid then passes from the container or fluid filledtubing into a syringe or second set of tubing. These connectors andadaptors often have mechanical or moving parts. Since the ready passageof fluids through the connectors and adaptors is often critical topatient survival, it is imperative that the connectors and adaptorsfunction reliably and repeatedly. Adaptors and connectors thatmalfunction during use may be life-threatening. The more mechanical ormoving parts such as springs and diaphragms, the more likely that theywill function improperly. Improper functioning can result in theintroduction of air embolisms into a patient. Thus, the fewer themechanical parts, the more these connectors can be relied on and thebetter they will be accepted by the medical community.

[0006] Many connectors or valves, especially those employing severalmechanical components, have a relatively high volume of fluid spacewithin them. This “dead space” within the device prevents the accurateintroduction of precise fluid volumes and provides an opportunity forcontamination upon disconnection of the device. Connectors and adaptorsoften include valves that permit or interrupt the flow of fluid alongthe course of fluid travel. Several of those commonly in use employmetal needles to puncture sterile seals. Such connectors are generallydesigned to accommodate fluid flow in one direction. This means that thefluid line must have connectors and tube aligned in complementarydirections. These connectors often require further manipulation if, forexample, the valve is inadvertently assembled in a direction that willnot facilitate fluid flow. These manipulations increase handling,thereby increasing both the risk of contamination and the amount of timerequired to establish the fluid connection.

[0007] Metal needles employed as part of connector devices often havethrough-holes placed at the tip of the needle. Connection of the valvewith a flow line involves piercing the needle through a sealed septum.Through-holes placed at the needle tip can core the septum and releasefree particulates into the flow line. Such an event can prove fatal to apatient. Such through-holes may also become clogged easily with materialfrom the septum. Moreover, the use of a needle with a sharp point mayalso cause deterioration of the septum.

[0008] Reusable connectors and adaptors are preferred for medicalapplications since components must often be added or removed from afluid line connected to a patient. Reusable connectors, however, aredifficult to keep sterile. Sometimes caps are employed to cover theconnector to keep it sterile. Frequently, these caps are lost, or simplynot used because they are not readily available when needed.

[0009] A closed, patient access system that is easy to use and employsonly a valve device in communication with the patient that need not becapped or interconnected with the medical implement through a needle oradaptor, is swabbable, is sufficiently durable to maintain its functionafter several manipulations, and maintains a fluid-tight seal at highpressures, would be of great benefit to the medical community.

SUMMARY OF THE INVENTION

[0010] The valve of this invention has several features, no single oneof which is solely responsible for its desirable attributes. Withoutlimiting the scope of this invention as expressed by the claims whichfollow, its more prominent features will now be discussed briefly. Afterconsidering this discussion, and particularly after reading the sectionentitled, “Detailed Description of the Preferred Embodiments,” one willunderstand how the features of this invention provide its advantages,which include safety, reliable and repeatable performance, simplicity ofmanufacture and use, and provides long life without malfunction.

[0011] A preferred embodiment of a seal used in the present inventioncomprises a series of O-ring elements stacked together and connected toform a unitary structure. The O-ring elements have increasing diameters,with the smallest diameter element being adjacent the proximal end ofthe cavity. The O-ring element closest to the proximal end of the sealcontacts the wall of the spike proximal the through-holes when the sealis in a decompressed state, thereby preventing fluid from leaking fromthe interior of the spike through the proximal opening in the housing.It is desirable that at least the next immediate O-ring element also bein contact with the spike proximate the through-holes. Such a designprevents fluid from applying enough pressure on the slit to force theslit open while the seal is in the decompressed state. With thepreferred embodiment fluid may reside in the spike and between the spikeand the seal distal the through-holes without opening the slit in theseal cap. The seal is designed so that if this fluid pushes the sealupwards slightly, lifting the first and second O-ring elements upwardsand off the spike, the O-ring elements immediately distal the first andsecond elements move up and contact the spike so as to ensure that fluiddoes not flow through the seal cap and out of the valve. Maintainingthis contact around the spike avoids having fluid pressure on the slitforce the slit open, permitting the valve to leak.

[0012] In another feature of the present invention, the housing isprovided with fluid escape space, such as a groove or channel, to permitfluid contained between the exterior of the seal and the housing toescape during compression of the seal. In one embodiment, the proximalend of the housing is provided with at least one groove extending fromthe proximal end of the housing to indentations contained within thehousing. During the compression of the seal, fluid between the exteriorof the seal and the housing travels in a proximal direction through thegrooves and out of the valve through the proximal end of the housing. Inanother embodiment, a channel is provided as the fluid escape spacethrough the side wall of the housing. As the seal is compressed, fluidbetween the exterior of the seal and the housing travels through thechannel to the exterior of the valve. As discussed in greater detailbelow, providing a groove or channel to permit fluid between theexterior of the seal and the housing side wall to escape from the valveduring compression of the seal, provides several advantages.

BRIEF DESCRIPTION OF THE DRAWING

[0013] The preferred embodiments of this invention, illustrating all itsfeatures, will now be discussed in detail. These embodiments depict thenovel and non-obvious methods and valves of this invention as well asthe medical implement indicators and methods of use thereof, as shown inthe accompanying drawing, which is for illustrative purposes only. Thisdrawing includes the following Figures, with like numerals indicatinglike parts:

[0014]FIG. 1 is a perspective view of the first embodiment of a valveuseful in connection with this invention.

[0015]FIG. 2 is an exploded perspective view of the valve shown in FIG.1 illustrating spike, seal, and body or housing components of theinvention.

[0016]FIG. 3 is a longitudinal cross-sectional view of the assembledvalve of FIG. 1.

[0017]FIG. 4 is a schematic, longitudinal, cross-sectional view of theassembled valve of FIG. 1 before compressing the seal.

[0018]FIG. 5 is a schematic, longitudinal, cross-sectional view similarto FIG. 4 showing the valve during compression of the seal.

[0019]FIG. 6 is a perspective view of a second embodiment of a valveuseful in connection with the present invention.

[0020]FIG. 7 is a longitudinal cross-sectional view of the valve of FIG.6.

[0021]FIG. 8 is a schematic illustration of an ANSI delivery end of amedical implement compressing the seal of a valve.

[0022]FIG. 9 is a side elevation view, partially in cross-section, of anembodiment of the seal.

[0023]FIG. 10 is a longitudinal cross-sectional view of the assembledvalve of FIG. 1 using the seal of FIG. 9.

[0024]FIG. 11 is a longitudinal cross-sectional view of the assembledvalve of FIG. 1 using another embodiment of the seal.

[0025]FIG. 12 is a longitudinal cross-sectional view of the assembledvalve of FIG. 1 using yet another embodiment of the seal.

[0026]FIG. 13 is a longitudinal cross-sectional view of an additionalembodiment of the seal.

[0027]FIG. 14 is a longitudinal section of the seal shown in FIG. 13used in connection with the spike device shown in FIG. 2.

[0028]FIG. 15 is a longitudinal partial cross-sectional view of a stillfurther embodiment of the seal of this invention.

[0029]FIG. 16 is a longitudinal cross-sectional view, after assembly, ofthe valve shown utilizing the seal of FIG. 15.

[0030]FIG. 17 is a longitudinal cross-sectional view, after assembly, ofthe valve shown utilizing still another embodiment of the seal.

[0031]FIG. 18 is a longitudinal cross-sectional view, after assembly, ofthe valve utilizing yet one more embodiment of the seal.

[0032]FIG. 19 is a side elevation view, after assembly, of the seal andspike shown in FIG. 14 connected to the body or housing shown in FIGS.20 and 21.

[0033]FIG. 20 is a cross-sectional view taken along line 20-20 of FIG.19.

[0034]FIG. 21 is a perspective view of the housing shown in FIG. 19,with sections broken away to show the wall structure of the cavitycontaining the seal shown in FIGS. 13 and 14.

[0035]FIG. 22 is a greatly enlarged, cross-sectional view taken alongline 22-22 of FIG. 14.

[0036]FIG. 23 is a longitudinal cross-sectional view of anotherpreferred embodiment of the seal.

[0037]FIG. 24 is a partial cross-sectional view, after assembly, of thevalve shown utilizing the seal of FIG. 23 and another preferredembodiment of the spike.

[0038]FIG. 25 is a partial cross-sectional view of the valve of FIG. 24,illustrating grooves in the housing.

[0039]FIG. 26a is a top view of the valve of FIG. 25, illustrating thegrooves in the housing.

[0040]FIG. 26b is a top view of another preferred embodiment of thevalve with a channel shown in phantom through the side wall of thevalve.

[0041]FIG. 27 is a partial cross-sectional view of the valve of FIG. 26billustrating the channel.

[0042]FIG. 28 is a perspective view of the housing, with sections brokenaway to show the wall structure of the cavity containing the seal,including the groove in the housing.

[0043]FIG. 29 is an elevational view of a preferred embodiment of thehousing with a channel through the housing wall shown in phantom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] The term “proximal” is used to denote the end of the valve andother components at or near the spike tip 32 in FIGS. 2 through 5, 10through 12, 14, 16, 24, 25 and 27, and at or near the spike tip 60 inFIG. 6, and at or near the seal cap 92 in FIGS. 8, 9, 13 through 19, 23,24, 25 and 27. The term “distal” is used to denote the opposite end ofthe valve, or spike tip, or seal. The term “medical implement” is usedto denote any medical tool known to those of skill in the art that canfacilitate the passage of fluids, particularly liquids, therethrough.Examples of medical implements that are contemplated include, but arenot limited to, tubing, conduit, syringes, IV sets (both peripheral andcentral lines), piggyback lines, medical valves, and other components.Medical implements are commercially available in standard sizes. Thus,either or both ends of the valve can be provided with fittings toaccommodate such standard size medical implements.

[0045] The valve is a closed, patient access system which automaticallyreseals after administering medication using a medical implement thatdirectly connects with the system without the need of any intermediateneedles, caps or adaptors. A two-way valve is employed utilizing areusable seal that may be repeatedly pierced by an enclosed, protectedspike rather than an exposed metal needle. The valve facilitates fluid,particularly liquid, transfer while maintaining sterility. The valve iseasy to use and is capable of locking in place. After use, the valve isswabbed in the conventional manner with a suitable substance to maintainsterility. The design of the valve avoids accidental needle sticks. Aswill be discussed in detail below, the valve is useful as a medicalconnector or adaptor to enable liquid flow from a sealed container.

[0046] The first feature of the invention is that the valve has a bodyincluding a wall structure defining an internal cavity having a proximalend and a distal end. The cavity has an open space into which the sealis pushed, and preferably has a plurality of radial indentations in thewall structure that are adjacent the seal to accommodate the expansionof the seal upon compression. The proximal end has an openingsufficiently large to receive a delivery end of a medical implementwhich transfers fluid through the delivery end. In most applications,the delivery end of the implement is tapered inward so that the wallstructure and the tapered delivery end fit snug against each other uponinsertion of the delivery end into the opening. The proximal end of thecavity preferably is adapted to fit snug with an ANSI (American NationalStandards Institute, Washington, D.C.) standard end of the medicalimplement. Typically, the implement is a syringe, a connector orinlet/outlet of an IV set, or any one of a wide variety of conduits usedin medical applications.

[0047] The second feature is that the spike has a tip with at least onehole located at or near the tip, and a passageway in communication withthe hole that allows fluid to flow through this hole. Preferably, thehole is in a side of the spike adjacent the tip and is elongated, havinga size of 18 gauge or greater. More than one hole is desirable for manyapplications, and three, symmetrically located holes inward of theproximal end are preferred. The spike is seated inside the cavity andthe tip is embedded in the seal cap located at the proximal end of theseal. The tip of the spike is blunt and rounded so as to avoiddeterioration of the seal from repeated penetration by the spike. Thespike may include at least one rib which allows air to enter a spacebetween the seal and the spike, thereby facilitating the sealing of theopening when the implement is removed. The spike may have asubstantially conical shape, and the seal has a complementarily,substantially conical shaped cavity within it conforming to the shape ofthe spike.

[0048] The third feature is that the resilient seal is adapted to bemoved into a compressed state upon insertion of the tip of the medicalimplement into the opening and returns to a decompressed state uponremoval of the tip. The seal in the decompressed state has a sectionwhich fills essentially completely a portion of the cavity adjacent theopening. In the compressed state, the seal section is pushed by thedelivery end of the medical implement away from the opening and into thecavity. This seal section, known as the seal cap, may have a precut slitin which the proximal end of the spike is embedded. The delivery end ofthe implement and the seal are adapted to engage so that when the tip ofthe spike pierces the seal there is essentially no dead space betweensaid delivery end and the seal. Consequently, a predetermined dosageamount of medication is transferred in its entirety to the patient usingthis invention, with none of the prescribed amount being collected indead space in the valve. The delivery of an exact amount of medicationmay be critical in some situations when chemotherapeutic agents arebeing administered or small children are being treated.

[0049] As best shown in FIGS. 1 and 2, the first embodiment of valve 10,includes a valve body or housing 12, a spike element 24, and a seal 36.The seal 36 is prepared from a resilient material that is flexible,inert, impermeable to fluid, and readily pierceable by the spike 26. Inthe valve embodiment shown in FIG. 13 depicting an alternate shaped seal36 d, this seal 36 d has a precut slit 11 in its proximal end. Thisprovides a tiny orifice through which the tip 32 of the spike element 24may easily pass, yet still provides a fluid tight seal upon withdrawalof the spike element. These three components are assembled, as depictedin FIG. 3, with the spike element 24 enclosed to prevent accidentalsticks. FIG. 2 illustrates how the housing 12, seal 36, and spikeelement 24 are attached without the need to use any adhesive or otherbonding agent or process. Mechanical connection which provides a fluidtight closure is attained as is discussed subsequently. As shown inFIGS. 4 and 5, the seal 36 moves within the housing 12, being pierced bythe spike element 24 to expose the tip 32 of the spike element 24 toallow fluid to flow through the valve 10.

[0050] Referring to FIG. 1, one preferred embodiment of the housing 12has a bell-shaped skirt 16 and an upper, preferably cylindrical, conduit20. The skirt 16 is integral with, and connected by an annular ring 14,to the upper conduit 20. The skirt 16 creates a shield for an innerconduit 18 of the spike element 24. This inner conduit 18 is preferablycylindrical in shape, and slightly tapered. Inner conduit 18 and upperconduit 20 comprise aligned hollow tubes so that inner conduit 18 andupper conduit 20 are in fluid communication with one another when thespike element 24 pierces the seal 36. There is an annular lip 25surrounding a circular opening 25 a in the top of the conduit 20 (seeFIG. 2).

[0051] In the first embodiment of the valve, the upper conduit 20 isadapted to receive the tip or nose 48 of an ANSI standard syringe 46(see FIGS. 4 and 5). It is, however, contemplated that the outerdiameter of the upper conduit 20 can be of any size to accommodate theattachment of other connector devices thereto. Advantageously, theproximal end of the upper conduit 20 can be equipped with a lockingmechanism to facilitate locking of the valve 10 to a variety of medicalimplements. For example, referring to FIG. 1, locking ears 22 near theproximal lip 25 of housing 12 are preferably provided such that thehousing 12 can be locked into any compatible Luer-Lock device known tothose with skill in the art. For example, referring to FIG. 19,conventional Luer-Lock threads 180 can be provided on the outer diameterof upper conduit 20.

[0052] Referring to FIG. 2, the spike element 24 has at its distal endthe inner conduit 18 and at its proximal end a hollow spike 26 which isintegral with the inner conduit. The inner conduit 18 and spike 26present a continuous passageway for fluid during use. An annular cuff 28on an intermediate portion of the spike element 24 is integral with, andinterconnects, the inner conduit 18 and the spike 26. As illustrated inFIG. 3, the rim 28 a of the cuff 28 abuts the underside of the innerring 14, and has an annular detent 28 b that snaps into an annulargroove 14 b in the underside of the ring. The cuff 28 serves twofunctions. First, it serves as an attachment device to the underside ofthe annular ring 14. Second, it serves as a support and attachmentdevice for the seal 36.

[0053] The hollow spike 26 has a tapered conical shape, ending in asharp, pointed tip 32. Preferably, along the length of the spike areraised, protruding ridges 30. These raised ridges 30 extend from thesurface of the spike preferably between 0.2-2.0 mm. The ridges 30 arepreferably aligned along the length of the spike as illustrated in FIG.2. These ridges 30 serve to break any vacuum created when the spike 26is sealed as described hereinbelow. Modifications to the alignment andorientation of the ridges are discussed hereinbelow in association withtheir function. Distal the spike tip 32, there is situated at least onelongitudinal through-hole 34 to permit fluid communication between theinner conduit 18 and the upper conduit 20. Preferably, there are threethrough-holes 34 within about 10 mm and more preferably within about 5mm from the spike tip 32. These through-holes 34 may be of any size,however, the larger the size of the through-holes the greater the fluidflow rate through the valve 10. In a preferred valve embodiment, thesize of the through-holes 34 are 18-gauge to provide a flow rate threetimes that of a standard 18-gauge needle.

[0054] The seal 36 preferably has a seal cap 40 with a generally flattop surface 40 b, an outwardly tapered side wall 38, and a lower lip 42.Its interior is hollow to provide the conically shaped cavity 37 (FIG.3). Thus, the seal 36 slips easily over the spike element 24 to fitsnugly within the cavity 37. The seal lip 42 is seated within theannular cuff 28 and wedged between the cuff and the underside of thering 14. There are longitudinal grooves 43 (FIG. 2) along the length ofthe seal 36 which provide air pockets that facilitate compression of theseal 36 during use. The grooves 43 may be of variable shape or size tofacilitate seal compression. In the first valve embodiment, there is asingle groove 43 which completely surrounds the seal 36 between the sealcap 40 and the lip 42.

[0055] The base of the seal 36 has a width such that the seal lip 42fits snugly into the annular cuff 28. The hollow interior or cavity 37(FIG. 3) of the seal 36 is preferably tapered to conform internally tothe shape of the spike 24, having a wall portion 44 which contacts thespike 24 distal seal cap 40. The exterior of the seal 36 is sized andshaped to fit inside the upper conduit 20 of the housing 12. The cap 40reseals the valve 10 when the top surface 40 b is proximal thethrough-holes 34. Preferably, the cap 40 substantially fills the opening25 a in the top of the conduit 20. Thus, after assembly, the top surface40 b of the seal cap 40 is essentially flush with the lip 25, so thatthe lip 25 and seal cap 40 can be swabbed with alcohol or otherdisinfectant without leakage of disinfectant into the valve 10. It isimportant that the surface 40 b be exposed so that it may be swabbedwith a disinfectant.

[0056] As best shown in FIG. 3, the spike 24, with contiguous innerconduit 18, is affixed to the housing 12 through the association of theexternal potion of annular cuff 28 and the internal portion of annularring 14. Although not necessarily required, these two pieces may beaffixed by any one of a variety of methods known to those of skill inthe art including, but not limited to, heat sealing, glue, pressurelock, bonding or the like. The seal 36 fits into the annular cuff 28 andis held in place by an internal lip 27 along the internal portion of theannular ring 14 of the housing 12. The length of the spike 24 is suchthat, after assembly, the tip of the spike rests below the plane definedby the lip 25 of the housing 12. Preferably, the spike tip 32 isapproximately from 0.525″ to 0.1″ below the lip 25 of the housing 12.The seal 36 fits snugly against the spike 24 and is essentially flushwith the lip 25 of the housing 12. The spike tip 32 is thus embeddedwithin the seal cap 40 prior to use or may be approximately 0.025″distal the seal cap 40 when the valve 10 is in the closed position. Theinner conduit 18 is partially shielded by the bell shaped skirt 16 ofthe housing 12 (see FIGS. 1-3). The inner surface of the bell shapedskirt 16 preferably has protruding threads 44 as an optional lockingmechanism for attaching a medical implement thereto. Further, othermedical devices can be pressure fit over the outer portion of innerconduit 18 without direct association with the protruding threads 44.

[0057] During use, the valve is designed to be adapted as a two-wayvalve. The orientation of the valve is independent to fluid flow anddependent on the preferred orientation of the preexisting connections.Thus, the valve can be used as a valve connector for an intravenouscentral or peripheral piggyback connector in either orientation.Parenteral fluid is delivered to patients through tubing such that theliquid flows from a container through a piercing element into thepatient. The containers are frequently changed or additional fluidbottles are added. The valve disclosed herein is designed tointerconnect medical implements along the route of fluid delivery to thepatient. However, the valve is also useful in any environment in which aresealable fluid valve is desired. During use, a connector of theappropriate size is fitted over the inner conduit 18. Locking can beachieved by a Luer-Lock mechanism, a pressure fit or any other lockingmechanisms known to those with skill in the art, as described above.Thus, in one example, fluid passes from the inner conduit 18 into thespike 26. However, fluid flow is locked in place by the seal 36.

[0058]FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the medicalimplement connecting to the proximal end of the valve 10 is a syringe46. However, this connecting implement could be any number of medicalimplements known to those of skill in the art. The nose 48 of thesyringe 46 is placed on the seal cap 40 inside the lip 25 of the housing12. The application of pressure on the syringe 46 in the direction ofthe arrows, as illustrated in FIG. 4 creates pressure on seal cap 40.The resulting downward pressure compresses the seal 36. This pushes thetip 32 of the spike 26 through the seal cap 40 to expose thethrough-holes 34. Compression is facilitated by the grooves 38. Fluid isnow able to flow into the syringe 46, or vice versa, depending onwhether fluid is to be withdrawn from the patient or medication injectedinto the patient. FIG. 5 shows valve 10 opened by insertion of the nose48 of the syringe 46 into the opening 25 a. A syringe plunger 49 in thesyringe 46 is retracted thereby creating a vacuum to draw fluid throughthe valve 10 into the syringe. For intravenous applications, the valve10 can be orientated in the position diagramed in FIGS. 4 and 5, or itcan be rotated 1800 such that fluid flows in the opposite direction.

[0059] Upon removal of the syringe from the spike 26, as shown in FIG.4, the seal 36 is free to return to its original shape and cover thethrough-holes 34. The ability of the seal 36 to return to its originalshape is determined by the resiliency of the material used to preparethe seal 36. In addition, the ability of the seal 36 to return to itsoriginal shape is facilitated by the protruding ridges 30 formed on theexternal surface of the spike. During compression, a vacuum may form inthe area between the spike 26 and the seal 36, thereby preventing theseal 36 from returning to its original position. The protruding ridges30 permit air to pass along the spike/seal interface to prevent vacuumformation and allow free return of the seal 36. The ability of the seal36 to deform reversibly and return to its original position isparticularly useful because (1) it immediately stops fluid flow throughthe valve 10, (2) it covers the recessed spike 26 to maintain itssterility, and (3) it reduces the risk that the spike couldinadvertently pierce another object or person. In addition, since thevalve 10 lacks movable parts, except for the seal, it is unlikely thatwhen the seal 36 is pushed down, the valve 10 would fail to function.

[0060] Advantageously, the through-holes 34 are located relatively lowon the spike 26. Thus, the through-holes 34 are sealed relatively earlyin the process as the seal 36 returns to its original configuration whenthe valve 10 is closed. In one preferred embodiment of the valve, thethrough-holes 34 are located 0.075″ below the spike tip 32 (see FIG. 2).Additionally, the through-holes 34 are sealed even if the seal 36 doesnot fully return to its original configuration depicted in FIG. 4.Further, the ability of the seal 36 to return reversibly to its originalposition permits the reuse of the valve 10. Following disconnection, andbefore reuse, the surface of pierced seal cap 40 is essentially flushwith the housing 12. Thus, this flush surface can advantageously besterilized with alcohol or other surface decontaminating substances. Theskirt 16 and upper conduit 20 advantageously shield both connectionsfrom the surrounding environment to protect the sterility of theconnection. Further, both the skirt 16 and upper conduit 20 function ascollection reservoirs to prevent fluid from dripping from the valve 10during manipulation.

[0061] A cover cap (not shown) can be supplied to fit over the upperconduit 20 as further protection for the seal surface between use. Sucha cover cap, however, is not needed to maintain sterility since the seal36 may be swabbed with a disinfectant after each use. The reversibilityof the seal 36 makes the valve 10 particularly attractive as a connectorvalve to provide fluid communication between two fluid lines. Therefore,the valve provides for placing a first fluid line in communication witha second fluid line using the valve disclosed herein. The reversibilityof the valve 10 permits multiple fluid lines to be successively added,for example, to a fluid line in direct communication with a patient'svein. Since the valve is easily sterilizable and sealable, fluid linescan be added and removed without disconnecting venous contact.

[0062] The valve 10 is preferably prepared from a hard plastic, such asABS plastic, but it is additionally contemplated that the valve could beprepared from other medically inert materials known to those in the art.The spike element 24 is preferably prepared from the same material asthe housing 12. However, a stronger material, such as a poly-carbonatematerial, may be desirous for the spike element 24 to enable it topierce a variety of connecting septums and seals. One particularadvantage of this valve is that it does not rely on the use of metalneedles. This dramatically reduces the risk of skin puncture during useand manufacture. Further, the upper conduit 20 serves as a shield to thespike 26 such that skin contact with the spike 26 is further reduced.The spike 26 need only be strong enough to penetrate the seal cap 40, orif necessary, to pierce a connecting septum.

[0063] In the embodiment of the valve illustrated in FIGS. 2-4, thethrough-holes 34 are placed distal spike tip 32. This placement providestwo important advantages. First, the placement of the through-holes 34facilitates resealing of the valve 10 after use. Second, if thethrough-holes were placed at the spike tip 32, the holes 34 may core theseal cap 40 thereby introducing seal particulate into the fluid flow andpossibly plug the holes 34. Thus, the longitudinal placement of thethrough-holes distal the spike tip 32 prevents the introduction ofparticulates into the fluid path and/or plugging of the through-holes34. It is additionally contemplated that the number and diameter of thethrough-holes 34 can be adjusted to accommodate different fluidvelocities. In a preferred embodiment of the valve, the preferredvelocity of fluid passing through the through-holes 34 is equal to orgreater than the flow rate through an 18-gauge needle. Through-holeslarger than 18 gauge will, of course, facilitate greater fluid flowrates.

[0064] An important advantage of the valve 10 is that it has very littledead space, thus the volume of liquid entering into the valve 10 issubstantially equivalent to the volume of fluid leaving the valve 10.Further, the total equivalent fluid volume of the valve is very smallsuch that the volume of fluid flowing through the system in order toplace the valve 10 in fluid communication with a medical implement suchas a syringe 46 is substantially zero.

[0065] In another preferred embodiment of the valve, illustrated byFIGS. 6 and 7, a disposable sterile adaptor valve 50 is provided tofunction as a resealable lid for a container (not shown) of fluid. Thefluid can thus be removed from the fluid container or permitted to flowfrom the container into a medical implement adapted to house fluid in asterile manner. As is the conventional practice, an open mouth of thecontainer will ordinarily be sealed with a cover member (not shown).

[0066]FIG. 6 shows an adaptor valve 50 having a body including anadaptor skirt 52. The adaptor skirt 52 will preferably fit snugly overthe open mouth of the container. The skirt 52 may be of any size toaccommodate a range of container sizes. A lengthwise slit 54 ispreferably provided in at least one location along the length of theskirt to ensure a snug fit between the skirt 52 and the container. Achamber 56, preferably tubular in configuration, extends upward from theskirt 52 and is similar in construction and design to the upper conduit20 of the first preferred valve embodiment. Similar to the first valveembodiment, the proximal portion of the valve may contain a lockingmechanism 59 that preferably comprises a Luer-Lock device or otherlocking device known to those of skill in the art.

[0067] As depicted in FIG. 7, a spike 58 extends upward through atubular chamber 56. A spike tip 60 is preferably recessed from aproximal lip 62 of the tubular chamber 56. In a closed position, thistip 60 is covered by a seal 64, which is essentially the same as seal36. Protruding ridges 66 and seal grooves 68 facilitate seal compressionand promote closure following use. Thus, in the closed position asillustrated in FIG. 7, the seal 64 covers the through-holes 70 toprevent fluid out-flow from the container. The adaptor valve 50 containsa second spike 72 which points in the opposite direction as the spike58. These spikes 52 and 72 are in fluid communication with each other.The spike 72 extends downward inside the adapter skirt 52. The twospikes preferably form one component of the valve 50 while the skirt 52and upper chamber form a second component. These two components can beassembled in a manner like that of the valve 10. The spike 72, like thespike 58, has longitudinal through-holes 74 and a tip 76. Thethrough-holes 74 are located inward of the tip 76. The adaptor valve 50is thus useable with containers holding sterile medicament having acover or septum seal at the open mouth of the container. Examples ofcontainers with such seals contemplated for use with this valve includedosage bottles for intramuscular injector antibiotic containers or thelike. However, it is also contemplated that the valve 50 can be adaptedwith its own seal and locking mechanism to permit the valve to beemployed on a variety of containers for medicaments or other fluids.Medicaments in these types of containers are preferably maintained understerile conditions and the volume and nature of the medicament is suchthat multiple aliquots are intermittently removed over time. If themedicament is reconstituted, then, during use, any covering over theopening on the container is removed to reveal the rubber septum. Theadaptor valve 50 is placed over the septum and direct pressure isapplied to pierce distal spike 72 through the septum and into thecontainer. A syringe or the like can then be applied, as depicted inFIG. 4, in association with the first preferred valve embodiment, towithdraw fluid from the container. The pressure of the nose 48 over thespike 58 pushes the spike tip 60 through the seal 64. At the same time,the seal 64 is compressed. Compression is accommodated by the sealgrooves 68. Fluid is withdrawn from the container and the syringe isremoved from the spike 58. Release of the pressure applied to the seal64 permits the seal 64 to return to its original configuration. Thespike ridges 66 facilitate movement of the seal 64.

[0068] Often the ingredients housed in containers are those that can belyophilized at purchase. Lyophilized ingredients require reconstitutionbefore use. If the medicament requires reconstitution before use, thensterile water, saline, or other fluid can be introduced into thecontainer before fluid is extracted. The two-way nature of the valvepermits this without any special adaptation. After the syringe isremoved, the adaptor valve 50 automatically seals. Subsequently,aliquots can be removed from the container by syringe or the like.Alcohol or other compatible surface sterilizing agents can be used towipe the lip 62 and seal 64 before each use. Similar to the first valveembodiment, it is additionally contemplated that a cap can be providedto fit over the upper chamber lip 62 between uses.

[0069] The adaptor valve 50 can be adapted to function as a medicamentadaptor for an intravenous container. In this case, the adaptor valve 50is placed on a medicament container for intravenous delivery andattached via tubing to an intravenous feed. Thus, the adaptor valve 50can be placed in fluid communication with a connector valve of FIG. 1 tofacilitate the flow of medicament from intravenous drip bottles.

[0070] An alternative embodiment of the seal, a seal 36 a, is shown inFIG. 9. The seal 36 a comprises a seal cap 92 at the proximal endthereof and a seal lip 96 at the distal end thereof. A cup-like annularflange 95 is provided proximal the seal cap 92. The seal cap 92 and seallip 96 are connected by a seal wall consisting of a plurality of ringedwall portions 94 that expand and collapse in an accordion like fashion.During compression of the seal 36 a, the diameter of the ringed wallportions 94 expand outward in the radial direction. There are airpockets 13 a (FIG. 10) between ring portions 94 and the housing and airpockets 13 b between the spike 24 and seal 36 a. The seal 36 a containsa cavity 98 distal the seal cap 92 and adjacent the ringed wall portions94. The seal 36 a interacts with the spike 26 (FIG. 2) and othercomponents of the valve in a similar fashion to the seal 36 of FIG. 2.

[0071] Referring to FIG. 10, the cup-like annular flange 95 can bestretched around the upper conduit 20 and held in place by an annularring 97. This creates a trampoline-like effect that assists returningthe seal 36 a to a decompressed state after withdrawal of a syringe (notshown). This embodiment has two advantages. First, the proximal end ofthe valve 10 can be swabbed with alcohol or other disinfectant withoutleakage of disinfectant into the valve 10. Second, by affixing thecup-like annular flange 95 to the upper conduit 20 at the proximal endthereof with the annular ring 97, the repeated deformation andreformation of the seal 36 a is assisted.

[0072] In an alternative embodiment of the seal, the seal 36 b is shownin connection with the valve 10 in FIG. 11. The seal 36 b is similar tothe seal 36 a shown in FIGS. 9 and 10, as the seal 36 a is comprised ofa seal cap 92, a side wall consisting of ringed wall portions 94 and aseal lip 96. The seal 36 a also has an outwardly extending ring 99 whichis at a right angle with respect to the longitudinal axis of the valve10. This ring 99 is used to attach the seal 36 b to the upper conduit20. Preferably, an upper conduit annular plug 20′ is inserted within theupper conduit 20 to create a tight fit between the perpendicular ring99, a ledge 101 in the upper conduit 20, and the plug 20′. The ring 99assists in the reformation of the seal 36 b to enclose the spike 26 uponwithdrawal of a syringe (not shown).

[0073] As shown in FIG. 12, the cup-like annular flange 95 and ring 99may both be used in connection with the valve 10, to provide the seal 36c. This seal 36 c, provides rapid reformation upon withdrawal of asyringe (not shown) and realizes the advantages of both the seals 36 aand 36 b.

[0074] Another alternative embodiment of the seal, a seal 36 d, is shownin FIG. 13. In this embodiment, the seal 36 d is comprised of a seal cap92, a seal lip 96, and a side wall 150 comprised of circular tires 100stacked in series one on top of an adjacent larger diameter lower tire.The circular tires 100 are preferably solid throughout the diameter ofthe cross-section thereof. These circular tires 100 will deform andreform upon, respectively, compression and decompression of the seal 36d, thereby exposing or covering a spike (not shown) as the case may be.

[0075] As mentioned above, preferably the seal 36 d has a precut slit 11in the cap 92 lying along the longitudinal axis of the valve 10. Theseal cap 92 has a unique configuration that insures that the slit 11closes and is sealed upon withdrawal of a syringe (not shown) andreformation of the seal 36 d. It includes an enlarged, internal,pressure responsive member 200 which is integral with the seal cap 92.Between the proximal end of the side wall 150 and the member 200 is anannular space 102 which is filled with the fluid in the cavity 98. Thisfluid is under pressure, for example at the blood pressure of thepatient to which the valve 10 is attached. Referring to FIG. 14, fluid,for example the patient's blood, flows through the holes 34 in the spike26, filling the cavity 102. This fluid presses against the exterior ofthe member 200, closing the slit 11 when the seal is decompressed asshown in FIGS. 14 and 19. The pressure from this fluid creates a highpressure seal which prevents fluid from escaping valve 10 through theslit 11. There is a semi-cylindrical annular flange tear ring 104 on theend of the member 200 which advantageously extends the useful life ofthe seal 36 d.

[0076] Preferably, there is a tear ring 104 integral with the member 200along the perimeter of the internal surface the member 200, and a slightsaucer-like depression 204 in the external surface of the seal. Thepressure responsive element in the decompressed state closes any orificein the seal 36 d to provide an essentially fluid-tight seal while in thedecompressed state. The pressure responsive member 200 enables the valveto maintain a fluid-tight seal even at very high pressures sometimesexperienced in medical applications, particularly when the valve 10 isconnected to a patient's artery. The center of the member 200 and theannular space 102 are coaxial with the entryway 11 a to the orifice 11.The pressurized fluid fills the annular space 102 to apply pressure thatcompresses the member 200 to tightly close the entryway 11 a to theorifice 11. In a preferred valve embodiment the distance from theentryway 11 a to the proximal end of the seal cap 92 is from 0.500 to0.075 inches and more preferably approximately 0.100 inch.

[0077] As best illustrated in FIG. 22, the tip 32 is designed to avoidtearing the seal. The tip 32 has three facets 210, 212, and 214 whichare joined with each other along parting lines a, b, and c. Thisjunction of the facets 210, 212, and 214 frequently is ragged and willtear the seal 36 d. This is prevented by the parting lines a, b, and c,or junctions, being disposed within recesses 220, 222, and 224,respectively, to provide “buried parting lines.”

[0078] Another alternative embodiment of the valve 10 using the seal 36d is shown in FIG. 8 and FIGS. 19 through 21. In this embodiment, theinner wall 160 of the upper end of the conduit 20 is provided with atleast one, and preferably, a plurality of radial indentations 107. Theindentations 107 are elongated and disposed generally parallel to thelongitudinal axis of the valve 10 in a symmetrical, star-likeconfiguration. Each indentation has opposed lateral edges 162 whichengage the seal 36 d upon compression of the seal 36 d. The indentationsprovide space into which the seal 36 d expands upon compression.

[0079] Another preferred embodiment of the seal 36 h is shown in FIGS.23 through 25 and 27. In this embodiment, the seal 36 h comprises a sealcap 92 having a saucer-like depression 204 (FIG. 23). The seal 36 hcontains a slit 11 having a proximal end adjacent depression 204 and adistal end 11 a at the distal end of seal cap 92. Referring to FIG. 23,circular tires 100 similar to those in FIG. 13 are provided. The seal 36h has an internal cavity 98. Further, the seal 36 h preferably has aseal lip 96 as discussed in more detail above.

[0080] As best shown in FIG. 8, the wall 181 of the proximal end of theupper conduit 20 is tapered inward at the same angle as the nose 48 ofthe syringe 46. In accordance with ANSI standards, the taper is 0.006inch per linear inch. The wall 182 of the syringe nose 48 bears againstthe wall 181 as the nose slides into the opening 25 a to push the seal36 d inward compressing it and forcing the tip 32 of the spike 36 toenter the slit 11. The seal 36 d expands upon compression to fillessentially completely the upper portions of the indentations 107. Somesections of the seal 36 d are wedged between the edges 162 and othersections fill the indentations 107. As the liquid flows through the nose48 through holes 34, air in the nose 48 is forced out of the nose 48 andexpelled from the valve 10 between the walls 181 and 182. Thus,essentially the entire prescribed dosage is delivered through the valve10 to the patient. Fluid flows through the through-holes 34, but doesnot leak between either the seal 36 d and the wall 181 or between theabutting walls 181 and 182.

[0081]FIGS. 15, 16, 17, and 18 depict embodiments of seals, namely, seal36 e, seal 36 f, and seal 36 g, which are substantially the same as theseals 36 a (FIG. 10), seal 36 b (FIG. 11), and seal 36 c (FIG. 12),except the side wall 150 employing the circular tires 100 is used inplace of the accordion wall portion 94.

[0082] Other components of the valve interact with the variousembodiments of the seal in a similar fashion to their interaction withseal 36 of FIG. 2. Prior to use of the valve 10, it is preferable thatthe seal caps 40 or 92 be pierced centrally by a steel needle in theaxial direction, precutting the seal to provide the slit 11 in order toallow for more rapid decompression and reformation of the seal uponpiercing by the spike 26. The seals are advantageously formed from amaterial which can repeatedly reseal and prevent fluid from flowingaround the seal material. The seal 36 should also be capable of beingforced down and then spring back into position to reseal the valve.Material that is too soft will not reseal effectively; however, will notbe capable of springing back after opening of the valve. Material thatis too hard will provide sufficient spring force; however, will noteffectively seal. Thus, in a preferred embodiment, the seal is formedfrom a silicone having a hardness in the range from 30-70 Shoredurometer units, and more preferably in the range 40-50 Shore durometerunits. A cure silicone polymer in the preferred hardness range isavailable from Wacker Silicone Corp. of Adrian, Mich. In some valveembodiments, it is desirable to provide additional lubricity to the seal36 to allow it to spring back and reseal more effectively. Dow ChemicalCo. produces a silicone formulation with silicone oil built in toprovide this additional lubricity.

[0083] In general, the closing of the valve 10 is provided not by theside wall of the seal 36 which immediately covers the through-holes 34,but by the seal cap 40, or seal cap 92 filling the proximal end of thecavity 98 and the opening 25 a. Thus, the seal caps 40 and 92 aresufficiently thick to reseal the opening 25 a effectively after valveclosure. However, the seal caps 40 and 92 should also be sufficientlythin to allow them to readily return to the closed position. Preferablythe thickness of the caps 40 and 92 ranges between 0.075 and 0.500 inchand more preferably may be approximately 0.100 inch.

[0084] The valve can be provided in a sterile and disposable form suchthat after its use in a given installation is exhausted, the device isdiscarded. However, as described above, in any given installation, thevalve can be reused multiple times. Since the valve does not employneedles, there is little chance that the device will inadvertently causeskin puncture. Therefore, the extra precautions required for handlingand disposing of needles is obviated. It will be apparent from thedetailed description provided herein that the valve can provide for theelimination of nearly all needles used in the medical environment. Withthe use of the valve described above, the need for all needles exceptthose that are directly input into a patient is, advantageously,eliminated.

[0085] The valve 10 is used to provide a closed, patient access systemfor transferring a predetermined amount of medication from a remotesource to the patient. The valve 10 is connected by the distal end tothe patient, for example, a vein or artery in fluid communication withthe valve. Blood fills the valve, but the seal 36 d, for example,prevents any blood from leaking from the valve. The delivery end or nose48 of the medical implement is inserted into the valve as depicted inFIG. 8, pushing the nose 48 against the seal to compress the sealsufficiently to allow the tip 32 of the spike 24 to pierce the seal andenter said delivery end. The predetermined amount of medication in itsentirety may now be transferred through the nose 48 into the valve 10and into the patient. Since the nose 48 and seal 36 d engage in a mannerso that the tip 32 of the spike element 24, upon piercing the seal,meets the seal to avoid formation of any dead space at the interfacebetween nose 48 and the seal surface 40 b. Transfer directly through thevalve 10 of essentially the entire predetermined amount of medicationfrom the syringe 46 to the patient, so that essentially none of saidpredetermined amount is collected in any dead space in the valve, isaccomplished. Upon withdrawing the nose 48 from the valve 10 the seal 36d returns to the decompressed state to close the valve and maintainwhile in said decompressed state a fluid tight seal even at highpressures and after repeated uses.

[0086] Another alternative embodiment of the seal, a seal 36 h, is shownin FIG. 23. In this embodiment, the seal 36 h is similar to seal 36 dand is comprised of a seal cap 92, seal lip 96, and a side wall 150comprised of circular tires 100 stacked in series one on top of anadjacent larger diameter lower tire. Side wall 150 defines cavity 98.The circular tires are preferably solid throughout the diameter of thecross-section thereof. These circular tires will deform and reform upon,respectively, compression and decompression of the seal 36 h, therebyexposing or covering a spike (not shown) as the case may be.

[0087] Seal 36 h also has a precut slit 11 in seal cap 92 lying alongthe longitudinal axis of the seal 36 h. Slit 11 remains sealed when seal36 h is in a decompressed state. As explained earlier, precutting theseal to provide slit 11 allows for more rapid decompression andreformation of the seal upon piercing by the spike. Unlike seal 36 d,however, seal cap 92 of seal 36 h is substantially solid without havingany pressure responsive member as is employed in seal cap 92 for seal 36d.

[0088] An alternative embodiment of the present invention using seal 36h is shown in FIG. 24. Spike 26 a, residing within cavity 98 and havinga proximal end with a tip 32 embedded in seal cap 92, is shown to bemore tubular, and less frustoconical than the spike 26 illustrated inother embodiments. Furthermore, the tip 32 of spike 26 a is a blunt,rounded end, unlike the pointed tip of spike 26. Because the end isrounded, the seal cap is not subjected to deterioration through tearingby spike tip 32. Thus a tear ring for the seal, as shown in FIG. 14 forexample, is not necessary for this embodiment.

[0089] Another feature of this embodiment is the arrangement of thespike 26 a with the seal 36 h when the seal 36 h is in a decompressedstate. In this state, rounded tip 32 of spike 36 h is positioned to beembedded in slit entryway 11 a, while slit 11 remains closed to anyfluid flow. FIG. 24 shows the entire rounded tip 32 in contact with thedistal end of seal cap 92. Additionally, the side wall circular tireclosest to the proximal end of the seal, tire 100 a, contacts the sidewall of spike 26 a. It is desirable that at least the next immediatedistal circular tire, tire 100 b, also be in contact with the spike 26 aproximate the through-hole 34. Having a plurality of tires in contactwith spike 26 a proximal through-hole 34 prevents fluid from passingfrom cavity 98 through the proximal end of the valve 10. Without such adesign, fluid would leak through through-hole 34, thereby applyingenough fluid pressure on slit 11 to force slit 11 open while the seal isstill in a decompressed state. Through-hole 34 should be distal thetires 100 a, 100 b, which contact spike 26 a, so that fluid passingthrough through-hole 34 will not apply pressure to slit 11, and insteadwill be blocked by circular tires 100 a and 100 b creating a sealbetween the spike 26 a and seal 36 h.

[0090] During medical applications, for example when the valve 10 isconnected to a patient's artery, the patient's blood flows through theholes 34 in spike 26 a, filling the area in cavity 98 distal the secondtire 100 b. Since the fluid residing between the first two tires, 100 aand 100 b, and between seal cap 92 and tire 100 a constitutes a verysmall volume, the fluid cannot exert enough pressure against the sealcap to open slit 11. Pre-cut seal cap 92 is designed to remain closed upto fluid pressure of 20 psi. Therefore, blood pressure will not open thevalve 10.

[0091] Upon connection of the distal end of valve 10 with a patient'sartery, however, as the blood pushes up against seal 36 h, the fluid mayforce seal cap 92 to move proximally, thereby also pushing the sidewalltires 100 in the proximal direction. This pressure may permit blood toflow past tires 100 a and 100 b to place pressure on the slit 11.However, due to increased fluid pressure, the tires immediately distalfirst and second tires 100 a and 100 b move proximally and contact thespike 26 a to take the original positions of tires 100 a and 100 b so asto ensure that a plurality of tires are always in contact with spike 26a. Because the sidewall tires 100 of seal 36 h are designed to bowoutward from the proximal to the distal end, the tires immediatelydistal tires 100 a and 100 b may not be in contact with spike 26 a whenin their original position. However, as will be understood by those ofskill in the art, if fluid flows through the spike 26 a, through-hole 34and into cavity 98 of seal 36 h, forcing the seal 36 h to move in aproximal direction, tires distal the first tire 100 a and second tire100 b will also move in a proximal direction and contact the spike 26 aproximally through-hole 34 strengthening the seal between the spike 26 aand the seal 36 h. That is, when fluid is not contained within thecavity 98 of the valve 10, only the first tire 100 a and second tire 100b contact the spike 26 a. However, once fluid is introduced into thecavity 98 of the valve 10, the seal 36 h may travel in a proximaldirection. If this occurs, tires directly distal second tire 100 bcontact seal 26 a in addition to the first tire 100 a and second tire100 b strengthening the seal between the seal 36 h and spike 26 a andpreventing fluid from traveling through spike 26 a, through thethrough-hole 34 into the cavity 98 and past the tires 100 to exertpressure on the slit 11 in the seal cap 92 of seal 36 h.

[0092] An alternative embodiment of the housing, housing 12 a, is shownin FIG. 25. In this partial cross-sectional view, housing 12 a issimilar to housing 12, except for grooves 303, 304 that are providedalong the longitudinal axis of the interior wall of the upper conduit20. The grooves 303, 304 are provided as fluid escape spaces to ensurethat a perfect seal between the seal cap 92 and the inner wall 305 ofthe upper conduit 20 is not provided. The grooves 303, 304 preferablyrun from the proximal end of the upper conduit 20 distally past theportion of the upper conduit 20 in contact with the seal cap 92. As bestseen in FIG. 28, the groove 303 preferably extends from the proximal endof the upper conduit 20 of the housing 12 a distally to the proximal endof the radial indentations 107.

[0093] Provision of the fluid escape spaces provides the advantage ofallowing any fluid residing in the space between the seal 36 h and theupper conduit 20 to exit the housing upon compression of the seal 36 h.Referring to FIG. 25, during routine use of the valve 10 in transferringfluid, fluid may seep into the section of the housing 12 a between theseal 36 h and the walls 305 of the upper conduit 20. When this area isfilled with fluid and the seal cap 92 is compressed distally by amedical implement (not shown), the user may experience difficulty inforcing the seal cap 92 distally past the through-hole 34 of the spike26 a, because the sidewall tires 100 no longer have any room within theupper conduit 20 to be compressed due to the presence of the fluid. Itis undesirable to require the user to apply extra force to compress theseal because oftentimes the user may twist the medical implement downonto the seal, leading to deterioration of the seal and eventualtearing. In addition, fluid between the seal 36 h and the inner wall 305of the upper conduit 20 of the housing 12 a may prevent the seal 36 hfrom compressing distal the through-hole 34 of the spike 26 a. As aresult, the valve 10 would not function properly.

[0094] By providing grooves 303, 304 as fluid escape spaces, fluidpresent between the seal 36 h and the inner wall 305 of the upperconduit 20 of the housing 12 a may travel proximally through the grooves303, 304 upon compression of the seal 36 h by a medical implement (notshown). As the fluid is expelled from the valve 10 through the grooves303, 304 at the proximal end of the housing 12 a, the seal 36 h maycompress normally without use of excessive force by a user of the valve10.

[0095]FIG. 26a is a top plan view of the valve shown in FIG. 25. Grooves303, 304 are shown in the upper conduit 20 of the housing 12 a of thevalve 10. Importantly, when the seal 36 h is compressed distally by amedical implement (not shown), the seal 36 h does not expand into thegrooves 303, 304 thereby preventing fluid flow therethrough.

[0096] Another alternative embodiment for the housing, housing 12 b, isshown in FIG. 29. The housing 12 b employs a channel 307 as a fluidescape space which is substantially perpendicular to the longitudinalaxis of the valve 10. A channel 307 is a bore that runs transverselythrough the side of the wall of the upper conduit 20, and is positioneddistal to any Luer Lock threads 309 or other locking mechanism that maysurround the upper conduit 20 near its proximal end. Similar to thegrooves 303, 304, the channel 307 provides a passageway for fluid withinthe area between the seal 36 and the inner wall 305 of the upper conduit20 to exit when the sidewall tires 100 are compressed and expand intothe radial indentations 107. Since an avenue exists for the fluid toexit this area, a user does not have to apply excessive force in pushinga medical implement (not shown) distally into the valve 10.

[0097]FIG. 26b is a top plan view of the valve 10 shown in FIG. 29. Thechannel 305 is shown in phantom and is preferably located in the upperconduit 20 of the housing 12 b of the valve 10. Upon compression of theseal 36 h by a medical implement (not shown), fluid between the upperconduit 20 and the seal 36 h is expelled from the valve 10 through thechannel 307 and out the side wall of the upper conduit 20. Thus, achannel 307 can be distinguished from a groove by its expulsion of fluidthrough a side wall, rather than the proximal end of the housing 12 a,as for a groove 303.

[0098] As will be easily understood by those of skill in the art, achannel and groove may be incorporated in combination to assist inexpelling fluid from the valve upon compression of the seal by a medicalimplement. For example, upon compression of the seal, fluid could travelthrough a groove proximally and thereafter through a channel incommunication with the groove. The channel could be located distally theproximal end of the valve. Moreover, a single groove or channel may beutilized or multiple grooves or channels may be incorporated into thevalve of the present invention as will be easily understood by those ofskill in the art.

[0099] Lack of a channel or groove as discussed above, may result indeterioration of the seal 36 and prevent the seal cap 92 from beingpushed completely below through-hole 34. If the through-hole is notcompletely open, the patient will not be able to receive a constant flowrate of medication. In some situations, the delivery of an exact amountof medication at a predetermined rate may be critical for treatment,and, therefore, through-hole 34 must be completely open for passage ofmedication from the medical implement. The groove and/or channel ensuresthat the seal cap may be pushed distally the through-hole and that theseal may be compressed without any excessive force which may causedamage to the seal.

The following is claimed:
 1. A medical valve for controlling the flow offluid between a first medical implement and a second medical implement,said valve comprising: a body comprising an opening adapted to receivethe first medical implement, and a wall structure defining an internalcavity adapted for fluid communication with the second medicalimplement, said cavity comprising a neck portion in fluid communicationwith said opening and a main portion with a larger internal diameterthan the neck portion; a flexible element positioned in said cavitymovable between an uncompressed position in which a portion of theflexible element bears against the wall structure near said opening andobstructs fluid flow through said valve and a compressed position inwhich fluid flow is permitted through said valve, said flexible elementcomprising a wall with an inner surface and an outer surface, the wallflexing to accommodate axial compression of said flexible element, saidflexible element comprising an end fitting against a ring-shaped supportto assist in securing said flexible element in said cavity, saidflexible element in said uncompressed position comprising a firstexternal diameter near said opening, a second external diameter in saidneck portion and a third external diameter in said main portion, saidsecond diameter being smaller than said first diameter and said thirddiameter, and at least a portion of the outer surface of the wall of theflexible element between the second diameter and the third diameterbeing tapered; and a fluid escape space in the wall structure of thebody for relieving fluid from a space between the flexible element andthe body in the cavity.
 2. The valve of claim 1, wherein the fluidescape space comprises at least one groove.
 3. The valve of claim 2,wherein the fluid escape space terminates at an end of the body adaptedto receive the first medical implement.
 4. The valve of claim 2, whereinthe fluid escape space terminates at a location on the outer surface ofthe body between an end adapted to receive the first medical implementand an opposite end adapted to receive the second medical implement. 5.The valve of claim 1, wherein an end of the flexible element near theopening of the body in its uncompressed position is substantially flat.6. The valve of claim 1, wherein said flexible element in theuncompressed position has an end substantially flush with the opening ofsaid cavity of said body.
 7. The valve of claim 1, further comprising: arigid member positioned within the flexible element to assist insupporting the flexible element and to assist in maintaining theflexible element along an axial centerline of the cavity when theflexible element moves between the uncompressed position and thecompressed position.
 8. The valve of claim 1, wherein the flexibleelement substantially completely fills the opening in its uncompressedposition.
 9. A medical valve for controlling the flow of fluid between afirst medical implement and a second medical implement, the valvecomprising: a body comprising an opening adapted to receive the firstmedical implement, and a wall structure defining an internal cavityadapted for fluid communication with the second medical implement, thecavity comprising a neck portion in fluid communication with the openingand a main portion with a larger internal diameter than the neckportion; a flexible element positioned in the cavity movable between anuncompressed position in which a portion of the flexible element bearsagainst the wall structure near the opening and obstructs fluid flowthrough the valve and a compressed position in which fluid flow ispermitted through the valve, the flexible element comprising a wall withan inner surface and an outer surface, the wall flexing to accommodateaxial compression of the flexible element, the flexible element in theuncompressed position comprising a first external diameter near theopening, a second external diameter in the neck portion and a thirdexternal diameter in the main portion, the second diameter being smallerthan the first diameter and the third diameter, and at least a portionof the outer surface of the wall of the flexible element between thesecond diameter and the third diameter being tapered; and a fluid escapespace in the wall structure of the body for relieving fluid from a spacebetween the flexible element and the body in the cavity.
 10. The valveof claim 9, wherein the fluid escape space comprises at least onegroove.
 11. The valve of claim 9, wherein the fluid escape spaceterminates at an end of the body adapted to receive the first medicalimplement.
 12. The valve of claim 9, wherein the fluid escape spaceterminates at a location on the outer surface of the body between an endadapted to receive the first medical implement and an opposite endadapted to receive the second medical implement.
 13. The valve of claim9, wherein an end of the flexible element near the opening of the bodyin its uncompressed position is substantially flat.
 14. The valve ofclaim 9, wherein the flexible element in the uncompressed position hasan end substantially flush with the opening of the cavity of the body.15. The valve of claim 9, further comprising: a rigid member positionedwithin the flexible element to assist in supporting the flexible elementand to assist in maintaining the flexible element along an axialcenterline of the cavity when the flexible element moves between theuncompressed position and the compressed position.
 16. The valve ofclaim 9, wherein the flexible element substantially completely fills theopening in its uncompressed position.
 17. A medical valve forcontrolling the flow of fluid between a first medical implement and asecond medical implement, the valve comprising: a body comprising anopening adapted to receive the first medical implement, and a wallstructure defining an internal cavity adapted for fluid communicationwith the second medical implement, the cavity comprising a neck portionin fluid communication with the opening and a main portion with a largerinternal diameter than the neck portion; a flexible element positionedin the cavity movable between an uncompressed position in which aportion of the flexible element bears against the wall structure nearthe opening and obstructs fluid flow through the valve and a compressedposition in which fluid flow is permitted through the valve, theflexible element comprising a wall with an inner surface and an outersurface, the wall flexing to accommodate axial compression of theflexible element, the flexible element in the uncompressed positioncomprising a first cross-section near the opening having a firstinternal diameter and a first external diameter, a second cross-sectionin the neck portion having a second internal diameter and a secondexternal diameter and a third cross-section in the main portion having athird internal diameter and a third external diameter, the secondexternal diameter being smaller than the first external diameter and thethird external diameter, and the third internal diameter being greaterthan the second internal diameter and the second internal diameter beinggreater than the first internal diameter; and a fluid escape space inthe wall structure of the body for relieving fluid from a space betweenthe flexible element and the body in the cavity.
 18. The valve of claim17, wherein the fluid escape space comprises at least one groove. 19.The valve of claim 17, wherein the fluid escape space terminates at anend of the body adapted to receive the first medical implement. Thevalve of claim 17, wherein the fluid escape space terminates at alocation on the outer surface of the body between an end adapted toreceive the first medical implement and an opposite end adapted toreceive the second medical implement.
 20. The valve of claim 17, whereinthe inner surface in the uncompressed position has a taper between thefirst cross-section and the second cross-section that is different thana taper between the second cross-section and the third cross-section.21. The valve of claim 17, wherein an end of the flexible element nearthe opening of the body in its uncompressed position is substantiallyflat.
 22. The valve of claim 17, wherein the flexible element in theuncompressed position has an end substantially flush with the opening ofthe cavity of the body.
 23. The valve of claim 17, wherein the flexibleelement substantially completely fills the opening in its uncompressedposition.